What if FDA and Medtech Worked Together on Quality?

Regulatory compliance doesn't always correlate with quality assurance. That was the revelation back in 2011 that led FDA to invite medical device companies to participate in industry forums aimed at understanding the barriers to medical device quality and finding ways to shift the focus from compliance to quality.

The problem is, people in the medical device industry tend to regard people from FDA as the men in black, and that mentality alone was a barrier.

"Those initial meetings were pretty interesting," Garth Conrad recalled during a panel discussion at the MD&M West Conference this week. "Back in 2011, when compliance was the key focus, you got in those meetings and nobody in industry wanted to talk. You know, you go to FDA's facility, big hall, hundreds of people that were there, and nobody from industry wanted to say anything because the challenge was, if we open our mouths they're going to know we're not compliant, we're going to tell them we have problems. We can't do that, it's the FDA."

Over time that barrier began to break down and Conrad said the larger medical device manufacturers were the first to the table to begin talking openly with the agency about the challenges they saw in the industry regarding quality.

"There was this general feedback that was coming from industry that we want to improve quality, however everything we're focused on from a regulation compliance standpoint really inhibits us from truly driving after the quality improvement of our products."

Around the same time research emerged showing the cost to manufacturers when they had to recall a product for quality assurance reasons.

FDA began to push for a focus on quality over compliance, enhanced transparency, and stakeholder engagement. That need for better stakeholder engagement led to the involvement of the Medical Device Innovation Consortium (MDIC), a public-private partnership focused on regulatory science.

"MDIC is a safe place where FDA and industry can talk, and talk about the challenges facing our industry, and talk about the barriers to quality," said Stephanie Christopher, program director of MDIC.

Today the Center for Devices and Radiological Health at the FDA is running a pilot program called the Medical Device Discovery Appraisal (MDDA) program that is helping the agency and medical device manufacturers see quality assurance in a new light. The program is designed to improve product quality with the end goal of benefiting patients, but it also offers cost and efficiency benefits to manufacturers.

Edwards Lifesciences is among the companies participating in the pilot program, and Rob Becker, director of quality at Edwards, said the MDDA audit that the company went through in 2017 ended up costing Edwards about $74,000 compared to a traditional compliance audit that would have cost closer to $140,000. What's more, Becker said the process involved minimal business interruption compared to what the company was used to dealing with in the compliance audit process.

The process identified 27 opportunities for Edwards to work on, but many of them aligned with what the company wanted to work on anyway.

"We're working on a lot of things we wouldn't have thought that we'd be working on as part of an FDA surveillance program," Becker said.

But that doesn't mean the agency is expecting Edwards to make all of these improvements at once, Cisco Vicentry, program manager for the Case for Quality program ta FDA, clarified.

"This is about your improvement," Vicentry said, emphasizing "your."

From an agency's standpoint, the MDDA program allows FDA to shift some of the other activities that it typically engages in and find ways to be more flexible as an agency.

"What happens at one company, what is right for that one company, is not necessarily what is right for the next company," Vicentry said. That means the agency shouldn't keep "jamming things into the same buckets," in terms of quality expectations, he said.

I am reminded of two things. One is a former student working in industry who told me that when she was a design engineering she considered the people from "quality" to be a pain. Then she became a Quality person... And I once asked a respected FDAer if "The QSR led to quality systems that in turn led to quality products?" In the spirit of my question he replied "That's our story and we are sticking to it." But "because we have to," or "because we don't have to" are rarely the quality answer.